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FDA NDA · NDA018874

CALCIJEX

Sponsor: ABBVIE

APPLICATION
NDA018874
TYPE
NDA
ORIGINAL APPROVAL
1986-09-25
LATEST ACTION
2012-03-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CALCIJEX · ReferenceDiscontinued
CALCITRIOL 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CALCIJEX · ReferenceDiscontinued
CALCITRIOL 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2012-03-09Labeling · Supplement 22 · standard — Letter ↗AP
2007-07-01Labeling · Supplement 19 · standard — Letter ↗AP
2001-11-16Efficacy · Supplement 16 · standard — Letter ↗AP
2001-05-07Manufacturing (CMC) · Supplement 15 · standardAP
2001-01-29Manufacturing (CMC) · Supplement 14 · standardAP
2000-09-15Manufacturing (CMC) · Supplement 13 · standardAP
2000-04-04Labeling · Supplement 10 · standardAP
1999-12-02Labeling · Supplement 12 · standardAP
1999-05-26Manufacturing (CMC) · Supplement 11 · standardAP
1997-12-31Labeling · Supplement 9 · standardAP
1997-06-10Labeling · Supplement 8 · standardAP
1996-10-22Efficacy · Supplement 7 · standardAP
1996-01-05Manufacturing (CMC) · Supplement 6 · standardAP
1995-10-31Manufacturing (CMC) · Supplement 4 · standardAP
1991-07-25Manufacturing (CMC) · Supplement 1 · standardAP
1990-04-04Labeling · Supplement 2AP
1986-09-25Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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